Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment

NCT06259032 | Completed

• 1 other identifier: 66156
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical alignment (MA) in total knee arthroplasty (TKA) is the most commonly used with well-documented long-term results, however 20% of patients express dissatisfaction following primary TKA. Alternative alignment philosophies have been proposed, aiming to improve patient clinical outcomes and satisfaction. However, evaluation is focused mainly on knee alignment, the pathological findings and other adaptational changes in the ankles and hips are usually neglected. Thia study aim to comparative effect between mechanical and functional alignment in patient undergone bilateral robotic TKA on ankle alignment and functional outcomes.

Conditions

Arthropathy of Knee

Outcome Measures

Primary Outcomes (4)

• Radiographic outcomes : Hip-knee-ankle angle

  angle in degree between line from center of head of Femur to intercondylar notch and line from tibial interspinous to center of tibial plafond

  pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

• Radiographic outcomes : Tibial plafond inclination

  angle in degree between subchondral plate of distal tibial articular surface and vertical axis

  pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

• Radiographic outcomes :Talar inclination

  angle in degree between talar dome and vertical axis

  pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

• Radiographic outcomes : Tibiotalar tilt angle

  angle in degree between subchondral plate of distal tibial articular surface and talar dome

  pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

Secondary Outcomes (4)

• Clinical outcomes : Knee injury and Osteoarthritis Outcome Score (KOOS)

  pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

• Clinical outcomes : American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score

  pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

• Quality of Life score : EQ-5D-5L

  pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

• Forgotten Joint Score

  pre-operative within 2 weeks and post-operative at 2,4,8,12 weeks

Other Outcomes (6)

• Other outcomes : soft tissue release

  intraoperative

• Other outcomes : operative time

  intraoperative

• Other outcomes : blood loss

  post operative with in 2 days

Study Arms (2)

Mechanical alignment

EXPERIMENTAL

Other: Mechanical alignment

Functional alignment

EXPERIMENTAL

Other: Functional alignment

Interventions

Mechanical alignment OTHER

Goal alignment in TKA with mechanical alignment, resection bone in perpendicular to mechanical axis of femur and tibia.

Mechanical alignment

Functional alignment OTHER

Goal alignment in TKA with functional alignment, resection of bone base on native joint line obliquity.

Functional alignment

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-80 years
• Symptomatic bilateral knee Osteoarthritis requiring primary TKA
• Willing to undergo bilateral simultaneous TKA
• Able to give informed consent

You may not qualify if:

• ligament deficiency requiring constrained prosthesis
• bone loss with augmentation need
• history of fracture around knee or previous osteotomy
• history of ankle fracture
• patient with neuromuscular disorder or movement disorder
• patient is unable to attend the study follow-up program

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 14, 2024
• Study Start: October 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)